Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty with Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone: Phase I Clinical Trial.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Tissue regeneration has become a promising treatment for craniomaxillofacial bone defects such as alveolar clefts. This study sought to assess the efficacy of lateral ramus cortical plate with buccal fat pad derived mesenchymal stem cells (BFSCs) in treatment of human alveolar cleft defects. Ten patients with unilateral anterior maxillary cleft met the inclusion criteria and were assigned to three treatment groups. First group was treated with anterior iliac crest (AIC) bone and a collagen membrane (AIC group), the second group was treated with lateral ramus cortical bone plate (LRCP) with BFSCs mounted on a natural bovine bone mineral (LRCP+BFSC), and the third group was treated with AIC bone, BFSCs cultured on natural bovine bone mineral, and a collagen membrane (AIC+BFSC). The amount of regenerated bone was measured using cone beam computed tomography 6 months postoperatively. AIC group showed the least amount of new bone formation (70 ± 10.40%). LRCP+BFSC group demonstrated defect closure and higher amounts of new bone formation (75 ± 3.5%) but less than AIC+BFSC (82.5 ± 6.45%), suggesting that use of BFSCs within LRCP cage and AIC may enhance bone regeneration in alveolar cleft bone defects; however, the differences were not statistically significant. This clinical trial was registered at clinicaltrial.gov with NCT02859025 identifier.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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